VOLUNTARY RECALL PLAN

FSMA-COMPLIANT RECALL PROCEDURES (21 CFR 117.139)

PLAN ADMINISTRATION

Document Control

Plan Approval

Prepared By:

Signature: ________________________________________

Printed Name: [________________________________]

Title: [________________________________]

Date: [__/__/____]

Approved By (Senior Management):

Signature: ________________________________________

Printed Name: [________________________________]

Title: [________________________________]

Date: [__/__/____]

SECTION 1: PURPOSE AND SCOPE

1.1 Purpose

This Recall Plan establishes procedures for the voluntary recall of food products manufactured, processed, packed, or held by [________________________________] (the "Company") in compliance with FDA regulations, including 21 CFR Part 7 and 21 CFR 117.139.

1.2 Scope

This plan applies to:

☐ All food products manufactured at this facility
☐ All food products processed at this facility
☐ All food products packed at this facility
☐ All food products held at this facility

Products Covered:

1.3 Regulatory Requirements

This plan fulfills requirements of:

☐ 21 CFR 117.139 - Recall Plan (Human Food)
☐ 21 CFR 507.38 - Recall Plan (Animal Food)
☐ 21 CFR Part 7 Subpart C - Recall guidance
☐ Company food safety plan requirements

SECTION 2: RECALL TEAM

2.1 Recall Coordinator

Backup Recall Coordinator:

2.2 Recall Team Members

2.3 External Contacts

SECTION 3: RECALL INITIATION CRITERIA

3.1 Potential Recall Triggers

A recall evaluation should be initiated upon:

☐ Consumer illness complaint linked to product
☐ Positive pathogen test result (production or environmental)
☐ Physical contamination discovery
☐ Undeclared allergen discovery
☐ Chemical contamination discovery
☐ Labeling error (safety-related)
☐ FDA or state agency notification
☐ Supplier notification of ingredient issue
☐ Foreign material complaints
☐ Out-of-specification test results
☐ HACCP/preventive control deviation
☐ Other: [________________________________]

3.2 Recall Classification (21 CFR 7.41)

3.3 Decision Authority

SECTION 4: RECALL PROCEDURES

4.1 Phase 1: Recall Initiation

Step 1: Identification and Assessment

Actions:
☐ Identify affected product(s)
☐ Identify lot/batch numbers involved
☐ Determine scope of distribution
☐ Assess potential health hazard
☐ Preserve product samples
☐ Quarantine any remaining inventory

Documentation Required:
☐ Complaint/incident report
☐ Production records
☐ Distribution records
☐ Test results (if applicable)

Step 2: Recall Team Assembly

Actions:
☐ Recall Coordinator notified
☐ Recall Team assembled
☐ Initial meeting conducted
☐ Roles and responsibilities confirmed
☐ Communication channels established

Initial Meeting Agenda:
1. Review of incident/issue
2. Product and distribution scope
3. Health hazard assessment
4. Preliminary recall classification
5. Resource allocation
6. Timeline establishment
7. Action item assignments

Step 3: Health Hazard Evaluation

Conduct health hazard evaluation considering:

☐ Disease, injuries, or deaths associated with product
☐ Assessment of hazard to various population segments
☐ Assessment of seriousness of the hazard
☐ Likelihood of occurrence of the hazard
☐ Consequences of continued distribution

Health Hazard Evaluation Documented: ☐ Yes

4.2 Phase 2: Notification

Step 4: FDA Notification (21 CFR 7.46)

Actions:
☐ Notify FDA District Office of recall initiation
☐ Provide required information:
☐ Product identification (name, description, codes)
☐ Reason for recall and hazard involved
☐ Date and circumstances of problem discovery
☐ Evaluation of risk
☐ Quantity of product involved
☐ Distribution information
☐ Copy of recall communication

FDA Contact:

Step 5: Consignee Notification (21 CFR 117.139(b)(1))

Recall Communication Must Include:

☐ "RECALL" prominently displayed (not "market withdrawal" or "stock recovery")
☐ Product name, description, identifying codes
☐ Reason for recall
☐ Specific action required (stop sale, return, destroy)
☐ Instructions for handling affected product
☐ Contact information for questions
☐ Request for confirmation of receipt and action taken

Notification Methods:

☐ Phone calls (priority for Class I)
☐ Email with read receipt
☐ Fax
☐ Overnight delivery
☐ Certified mail

Sub-Recall Notification:
☐ Instruct consignees to extend recall to their customers

4.3 Phase 3: Public Notification (21 CFR 117.139(b)(2))

Step 6: Public Notification (when appropriate)

Public notification appropriate when:

☐ Product may be in consumers' possession
☐ Health hazard is significant
☐ Wide distribution to consumers
☐ FDA recommends public notification

Public Notification Methods:

☐ Press release
☐ Company website
☐ Social media
☐ FDA posting (FDA will post in Enforcement Report)
☐ Direct consumer notification (if contact info available)
☐ Point-of-sale notices (retail)

Press Release Must Include:

☐ Product name, size, UPC, lot codes
☐ Reason for recall
☐ Potential health risk
☐ Instructions for consumers
☐ Photo of product/packaging
☐ Contact information
☐ Whether illnesses have been reported

4.4 Phase 4: Recall Execution

Step 7: Product Retrieval

Actions:
☐ Coordinate product return logistics
☐ Track product returned from each consignee
☐ Segregate and secure returned product
☐ Maintain chain of custody documentation
☐ Prevent re-entry into commerce

Product Tracking:

Step 8: Effectiveness Checks (21 CFR 117.139(b)(3))

Purpose: Verify that all consignees have received recall notification and taken appropriate action.

Effectiveness Check Levels:

Effectiveness Check Methods:

☐ Phone calls
☐ Personal visits
☐ Letters requiring response
☐ Combination

Documentation:

4.5 Phase 5: Product Disposition (21 CFR 117.139(b)(4))

Step 9: Product Disposition

Disposition Options:

☐ Destruction - Product destroyed under supervision
☐ Return to Manufacturer - Product returned for destruction/evaluation
☐ Reconditioning - Product reworked to eliminate hazard
☐ Conversion to Non-Food Use - Diverted to safe alternative use

Destruction Procedures:

☐ Witnessed destruction
☐ Certificate of destruction obtained
☐ Photos/video documentation
☐ Quantity destroyed recorded

Documentation:

4.6 Phase 6: Recall Termination

Step 10: Recall Completion

Recall may be terminated when:

☐ All consignees notified
☐ Effectiveness checks completed to required level
☐ All recoverable product accounted for
☐ Product properly disposed of
☐ FDA concurs with termination (recommended)

Recall Summary Report:

SECTION 5: RECORDS AND DOCUMENTATION

5.1 Traceability Requirements

The following records must be maintained and accessible within 24 hours:

☐ Production/batch records
☐ Ingredient lot traceability
☐ Shipping/distribution records
☐ Customer/consignee list with contact information
☐ Product coding/dating system documentation

5.2 Recall Records

Maintain complete records of:

☐ Health hazard evaluation
☐ Recall decision documentation
☐ FDA notification and communications
☐ Consignee notification copies
☐ Press releases and public communications
☐ Effectiveness check logs
☐ Product disposition records
☐ Recall team meeting minutes
☐ Final recall summary report

5.3 Record Retention

Recall records retained for: [____] years minimum (recommend 6+ years)

SECTION 6: MOCK RECALL EXERCISES

6.1 Exercise Requirements

Mock recalls shall be conducted:

☐ Annually
☐ Semi-annually
☐ When significant changes to products/distribution
☐ When key personnel change

6.2 Mock Recall Procedures

Exercise shall test:

☐ Product traceability (forward and backward)
☐ Consignee list accuracy
☐ Contact information accuracy
☐ Communication effectiveness
☐ Team response time
☐ Documentation completeness

6.3 Mock Recall Log

SECTION 7: COMMUNICATION TEMPLATES

7.1 Consignee Recall Letter Template

[See Attachment A]

Key elements:
- URGENT: PRODUCT RECALL header
- Product identification
- Reason for recall
- Required action
- Response form
- Contact information

7.2 Press Release Template

[See Attachment B]

Key elements:
- FOR IMMEDIATE RELEASE
- Product details and codes
- Reason for recall
- Consumer instructions
- Contact information
- Company statement

7.3 Consumer FAQ Template

[See Attachment C]

SECTION 8: ATTACHMENTS

☐ Attachment A: Consignee Recall Letter Template
☐ Attachment B: Press Release Template
☐ Attachment C: Consumer FAQ Template
☐ Attachment D: Recall Decision Tree
☐ Attachment E: Consignee List (maintained separately - confidential)
☐ Attachment F: FDA District Office Contact List
☐ Attachment G: Effectiveness Check Form
☐ Attachment H: Product Disposition Form
☐ Attachment I: Mock Recall Evaluation Form
☐ Attachment J: [________________________________]

SECTION 9: REVISION HISTORY

IMPORTANT REGULATORY NOTES

FSMA Recall Plan Requirements (21 CFR 117.139)

Written recall plan must include procedures that:
1. Notify direct consignees - including instructions for return/disposal
2. Notify the public - when appropriate to protect public health
3. Conduct effectiveness checks - verify recall is being carried out
4. Dispose of recalled product - appropriately (destroy, recondition, etc.)

FDA Notification

• Voluntary recalls should be reported to FDA
• FDA does not approve recalls but will classify and may recommend strategy changes
• FDA will post recall in weekly Enforcement Report

Recall vs. Market Withdrawal vs. Stock Recovery

• Recall: Firm's removal/correction of marketed product that FDA considers violative
• Market Withdrawal: Removal for minor issues not subject to FDA action (e.g., off-taste)
• Stock Recovery: Removal of product not yet distributed

Mandatory Recall Authority

Under FSMA Section 423, FDA has authority to order mandatory recall if:
- Reasonable probability of serious adverse health consequences or death
- Firm has not voluntarily recalled
- Other actions are not adequate

SOURCES AND REFERENCES

• 21 CFR Part 7 Subpart C - Recalls
• 21 CFR 117.139 - Recall Plan
• FDA Guidance: Initiation of Voluntary Recalls Under 21 CFR Part 7
• FDA Guidance: Product Recalls, Including Removals and Corrections
• FDA Regulatory Procedures Manual Chapter 7

This template is provided for informational purposes only. Each recall plan must be tailored to the specific facility and products involved. Consult with an FDA regulatory professional to ensure compliance.